Johnson & Johnson's Class 1 Oncology Drug JNJ-88998377 Receives IND Approval in China for B-cell Non-Hodgkin Lymphoma

According to the CDE official website, JNJ-88998377 oral tablets, a Class 1 new chemical drug developed by Johnson & Johnson (China) Investment Co., Ltd. ("Johnson & Johnson"), have received implied permission for clinical trials. The indications are B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], mucosa-associated lymphoid tissue lymphoma [MALT lymphoma], follicular lymphoma [FL], and Waldenström macroglobulinemia [WM]).

Image Source: CDE Official Website

01

Clinical Trials Initiated Both in China and Overseas

Sword Pointing at Lymphoma

Non-Hodgkin lymphoma is a group of lymphomas caused by abnormal development of lymphocytes (mainly B cells), commonly found in Asians. It mainly includes small lymphocytic lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma. According to statistics, there are about 84,000 new cases of lymphoma in China each year. The incidence rate of lymphoma is increasing at an annual rate of 5%, with the affected population showing trends of younger age and urbanization.

Johnson & Johnson has a strong presence in the oncology field, with marketed products such as DARZALEX and the B-cell maturation antigen (BCMA) CAR-T therapy developed in collaboration with Legend Biotech, among other key drugs. JNJ-88998377 is a novel oncology drug developed by Johnson & Johnson, which has already been registered for a clinical trial on the ClinicalTrials website.

Image Source: clinicaltrials.gov

This is a Phase I clinical dose-escalation study of JNJ-88998377 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), planning to enroll 160 participants, with the study expected to be completed by 2027.

After the clinical trial application for JNJ-88998377 successfully received approval from the CDE, Johnson & Johnson may initiate further research on it in China.

02

Oncology Field

Comprehensive Layout

As of April 16, Johnson & Johnson has nearly a hundred innovative drug projects under development. Particularly in the field of oncology, Johnson & Johnson has completed a comprehensive layout, covering various types of hematological malignancies and solid tumors, including indications such as prostate cancer and multiple myeloma.

Image Source: Johnson & Johnson

In Johnson & Johnson's early R&D pipeline, multiple projects have shown significant potential, with the possibility of becoming their next blockbuster product.

• VAC85135

VAC85135 is a neoantigen cancer vaccine co-developed by Johnson & Johnson and Nouscom. The vaccine is based on Nouscom's proprietary viral vector platform. According to the agreement, Johnson & Johnson will take full responsibility for the clinical development of VAC85135, while Nouscom will oversee its process development activities and GMP manufacturing. In May 2022, the Investigational New Drug (IND) application for VAC85135 was approved by the U.S. FDA and it is currently under clinical investigation.

• ARX305

ARX305 is a CD70 ADC developed by Ambrx (which has been acquired by Johnson & Johnson). It is composed of a humanized anti-CD70 monoclonal antibody covalently bound to two tubulin inhibitors, AS269. According to research, compared with traditional ADC drugs, ARX305 has more stable conjugation and high stability in the blood, showing good tumor suppression effects in multiple CD70-expressing tumor models.

• ARX517

ARX517 is also an ADC drug that targets prostate-specific membrane antigen (PSMA). This drug uses two synthetic amino acids as linkage sites on the PSMA monoclonal antibody molecule to enhance linkage stability and reduce off-target effects caused by premature payload release. In previously published research data, ARX517 demonstrated favorable therapeutic efficacy and safety.

• ARX788

ARX788 is a novel anti-HER2 antibody-drug conjugate (ADC), consisting of the site-specific conjugation of the anti-HER2 monoclonal antibody "trastuzumab" and a potent tubulin inhibitor payload, AS269, which incorporates non-natural amino acids into the antibody. This drug has demonstrated favorable safety and tumor response in studies treating Chinese patients with advanced HER2-positive breast cancer.

In addition, Johnson & Johnson has several undisclosed targets and types of projects in its oncology pipeline, with indications covering multiple myeloma, prostate cancer, and other diseases.

03

Conclusion

To date, Johnson & Johnson has established and put into operation a series of production bases and R&D centers in Shanghai, Suzhou, Xi'an, Guangzhou, Hangzhou, and other places. In particular, the Johnson & Johnson R&D center in Shanghai became the Asia-Pacific R&D center as early as 2009. In the future, as Johnson & Johnson's innovation and development accelerates, more significant products are expected to bear fruit in China.

Editor: Pea Shooter

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